antineoplaston therapy in treating adult patients with anaplastic astrocytoma

Conditions: Adult Brain Tumor

Summary: rationale: current therapies for adults with anaplastic astrocytoma provide limited benefit to the patient. the anti-cancer properties of antineoplaston therapy suggest that it may prove beneficial in the treatment of adults with anaplastic astrocytoma. purpose: this study is being performed to determine the effects (good and bad) that antineoplaston therapy has on adults with anaplastic astrocytoma.

objectives: * to determine the efficacy of antineoplaston therapy in adults with anaplastic astrocytoma as measured by an objective response to therapy (complete response, partial response) or stable disease. * to determine the safety and tolerance of antineoplaston therapy in adults with anaplastic astrocytoma. overview: this is a single arm, open-label study in which adults with anaplastic astrocytoma receive gradually escalating doses of intravenous antineoplaston therapy (atengenal + astugenal) until the maximum tolerated dose is reached. treatment continues for at least 12 months in the absence of disease progression or unacceptable toxicity. after 12 months, patients with a complete or partial response or with stable disease may continue treatment. to determine objective response, tumor size is measured utilizing mri scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter. projected accrual: a total of 20-40 patients will be accrued to this study

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed diagnosis of anaplastic astrocytoma * tumor subtotally resected or biopsied prior to therapy * evidence of residual tumor by mri scan performed within two weeks prior to study entry * no brain stem tumors patient characteristics: age: * 18 and over performance status: * karnofsky 60-100% life expectancy: * more than 2 months hematopoietic: * wbc at least 1,500/mm\^3 * platelet count at least 50,000/mm\^3 * hemoglobin at least 10 g/dl hepatic: * bilirubin no greater than 2.5 mg/dl * sgot and sgpt no greater than 5 times upper limit of normal * no hepatic failure renal: * creatinine no greater than 2.5 mg/dl * no renal failure cardiovascular: * no prior congestive heart failure * no coronary artery disease * no myocardial infarction within the past year * no angina requiring medication * no uncontrolled hypertension pulmonary: * no moderate to severe chronic obstructive pulmonary disease other: * not pregnant or nursing * fertile patients must use effective contraception during and for 4 weeks after study participation * no active infection * no other concurrent serious disease * no other prior malignancy except carcinoma in situ of the cervix or superficial nonmelanoma skin cancer prior concurrent therapy: biologic therapy: * no prior immunotherapy * no concurrent immunomodulating agents chemotherapy: * no prior myelosuppressive chemotherapy endocrine therapy: * concurrent corticosteroids for cerebral edema allowed radiotherapy: * no prior myelosuppressive radiotherapy * no concurrent radiotherapy surgery: * see disease characteristics * recovered from any prior surgery other: * no prior cytodifferentiating agents * no prior antineoplaston therapy * no other concurrent antineoplastic agents

Keywords: adult anaplastic astrocytoma